Given the profound public health and economic ramifications of decisions made by the U.S. Food and Drug Administration, the degree to which FDA activities should reflect an approach founded on complete transparency versus one focused on preserving confidentiality of information deserves public discussion. On one hand, reasonable requirements for transparency are critical to stimulating effective innovation, knowledge dissemination, and good business practice. On the other, ensuring the vitality of the medical products industry requires protecting legitimately proprietary information. With current standards reflecting a lengthy accumulation of legal, regulatory, and practical precedent, recent significant changes in the environment in which the FDA operates should prompt a critical examination of current practices. In this article, I comment on Sharfstein and colleagues’ “Blueprint for Transparency,” which calls for multiple specific actions to increase transparency at the agency across five key areas, including interactions between FDA and industry, public disclosure of internal FDA analyses, deliberations concerning generics and biosimilars, expanded access to raw study data, and approaches to countering misleading information in the public sphere. I evaluate these recommendations in light of my experience as a clinician, researcher, and former FDA Commissioner, and reflect on possible outcomes that could result from enacting these practices.

The legal doctrine of informed consent has overwhelmingly failed to assure that the medical treatment patients get is the treatment patients want. This Article describes and defends an ongoing shift toward shared decision making processes incorporating the use of certified patient decision aids.

This study explores the ways in which adolescents, even so-called “mature minors”, lack adequate development of the intellectual, affective, and emotional capacities necessary morally to consent to medical research on their own behalf. The psychological and neurophysiological data regarding brain maturation supports the conclusion that adolescents are qualitatively different types of agents than mature adults. They lack full adult maturity and personal agency. As a result, in addition to the usual requirements for IRB approval, one or both parents, or a legal guardian, should provide informed consent for minor children to participate in medical research.

Public health law has focused primarily on combatting stigma through laws targeting discrimination based on attributes (de jure), when the reach of stigma extends far beyond mere appearances. By exploring the lived experience of stigmatized individuals, policy makers might more deeply understand public health problems, more appropriately create health policies, and more effectively promote positive health behaviors. Efforts to address stigma must focus on all aspects of stigma to be effective.

Despite shifts in rhetoric and some positive movement, Americans with the disease of addiction are still often stigmatized, criminalized, and denied access to evidencebased care. Dramatically reducing the number of lives unnecessarily lost to overdose requires an evidence-based, equity-focused, well-funded, and coordinated response. We present in this brief article evidence-based and promising practices for improving and refocusing the response to this simmering public health crisis. Topics covered include improving clinical decision-making, improving access to non-judgmental evidence-based treatment, investing in comprehensive public health approaches to problematic drug use, and changing the way law enforcement actors interact with people who use drugs.

In this article, the author reviews the ways that the microaggressions framework has been taken up with regard to weight stigma by academics and activists and offers insight into its value for conceptualizing and challenging weight stigma.

From a clinical ethics perspective, I explore several traditional arguments that deem deception as morally unacceptable. For example, it is often argued that deception robs people of their autonomy (Frankfurt 2005). Deception also unfairly manipulates others and is a breach of important trust-relations (Williams 2009, Scanlon 1998). In these kinds of cases, I argue that the same reasons commonly used against deception can provide strong reasons why deception can be extremely beneficial for patients who lack mental capacity. For example, deception can enhance, rather than impair, autonomy in certain cases. I argue that deception ought to only be used after considering several key morally relevant factors and provide a practical and morally justifiable framework for exploring these issues.

When individual patients' medical decisions contribute to population-level trends, physicians may struggle with how to promote justice while maintaining respect for patient autonomy. This article argues that this tension might be resolved by using the informed consent conversation as an opportunity to position patients as societal stewards.

Transparency requires more than disclosure of data. It requires a mechanism and policy for conveying information to the public. In order for the aims of the excellent report of the FDA Transparency Working Group to be realized, a publicity initiative will need to accompany the plan of action. The FDA will need to actively convey information about the evidence concerning benefit-risk profiles of drugs, sometimes pointing out misleading claims by manufacturers or sponsors. In other cases, the FDA will need to make available its procedures, including possible conflicts of interest, not only in drug approval, but also in guidance documents and in rulemaking. Transparency as a process of letting the public see into the agency should be accompanied by a proactive strategy of distributing information about the products regulated by the agency.

In this paper I argue for recognizing the moral duty to participate in research. I base my argument on the need for biomedical research and the fact that at some point studies require human participants, what I call collaborative necessity. In presenting my position, I argue against the widely accepted views of Han Jonas and all of those who have accepted his declarations without challenge. I go on to show why it is both just and fair to invite and encourage people to participate in studies. It is just because research participation is the necessary means to achieve the broadly shared goals of preventing and curing disease and alleviating disease symptoms. Mutual love requires us to be willing to do for others what we would want them to do for us. It is fair because the approach treats similarly situated people in the same way. Research participation is morally required because failing to do one's part in the collaborative project of advancing biomedical science would be free-riding. People who exempt themselves from participation while eagerly accepting benefits from others doing their part are taking advantage of their compatriots and treating themselves as more deserving than others when they are not.

Commentators tout the societal benefits of research to conclude that people have a civic duty to participate in it. A review of several problems in research demonstrate the contrary and reveal why claims we are duty-bound to participate in research deter urgently needed efforts to tackle multiple entrenched deficiencies in it.

The Blueprint for Transparency at the FDA recommends that the FDA proactively release more clinical trial data. We show that the FDA possesses the legal authority to act on this recommendation, and describe several reasons that the agency should do so. In particular, the primary existing route for researchers to obtain access to this data, the Freedom of Information Act (FOIA), has important limits, as our own recent experience shows.

This article argues that public health campaigns have an ethical obligation to combat fat stigma, not mobilize it in the “war on obesity.” Fat stigma is conceptualized, and a review is undertaken of how pervasive fat stigma is across the world and across the lifespan. By reviewing the negative impacts of fat stigma on physical health, mental health, and health seeking behaviors, fat stigma is clearly identified as a social determinant of health. Considering the role of fat stigma in public health, and the arguments made for using stigmatisation in public health campaigns to promote population health, it is concluded that it is a violation of public health ethics to use stigma as a tool in combatting fatness. The article concludes by making recommendations of how public health in New Zealand can combat, rather than reinforce, fat stigma.

Protecting the public's health has always been an inherently political endeavor. The field of public health, however, is conspicuously and persistently absent from sustained, sophisticated engagement in political processes, particularly elections, that determine policy outcomes. This results, in large part, from widespread misunderstanding of rules governing how, and how much, public advocates working in tax-exempt organizations can participate in public policy development.

This article briefly summarizes the rules governing public policy engagement by exempt organizations. It then describes different types of exempt organizations, and how they can work together to expand engagement. Next, it identifies several key mechanisms of policy development that public health advocates could influence. Finally, it suggests some methods of applying the tax rules to increase participation in these arenas.

The Wisconsin Supreme Court, after adopting the doctrine of the objective (reasonable) patient standard, expanded it in bold and innovative ways over nearly four decades, until the Wisconsin legislative and executive branches drastically reversed this course. The saga has implications for other jurisdictions considering adoption or expansion of the objective patient standard doctrine

This paper examines the practice of covert medication administration from an organizational ethics perspective. This includes consideration of vulnerability and stigmatization, safety, and fairness (justice) in terms of the culture of health care organizations and the relevance of policies and processes in relation to covert medication administration. As much of the discussion about covert medication administration focuses on patients and health care providers, this analysis aims to help expand the analysis of this practice.

With the many changes occurring in today's healthcare organizations, patients are increasingly equipped with a vast quantity of health care data and being more included in the healthcare decision-making process. The new approach we propose incorporates a new patient-organization framework that examines relevant historical, legal and ethical elements within the doctrine of informed consent in addition to examining the role of new healthcare organizations' obligations to include data to support addressing issues such as population health, health outcomes and health disparities within the informed consent. There is a growing consensus among healthcare professionals that using an evidencebased organizational informed consent framework to improve the informed consent process can lead to better comprehension, health outcomes, transparency and improved patient trust and retention overall.

Developing ethical standards for clinical use of large-scale genome and exome sequencing has proven challenging, in part due to the inevitability of incidental or secondary findings. Policy of the American College of Medical Genetics and Genomics (ACMG) has evolved but remains problematic. In 2013, ACMG issued policy recommending mandatory analysis of 56 extra genes whenever sequencing was ordered for any indication, in order to ascertain positive findings in pathogenic and actionable genes. Widespread objection yielded a 2014 amendment allowing patients to opt-out from analysis of the extra genes. In 2015, ACMG published the amended policy, providing that patients could opt out of the full set of extra genes, but not a subset. In 2016, ACMG enlarged the set and indicated planned expansion of the roster of extra genes to include pharmacogenetic findings. ACMG policy does not protect the respect for patient choice that prevails in other domains of clinical medicine, where informed consent allows patients to opt in to desired testing. By creating an expanding domain of genomic testing that will be routinely conducted unless patients reject the entire set of extra tests, ACMG creates an exceptional domain clinical practice that is not supported by ethics or science.

This commentary addresses public health issues underlying homelessness and related law, policy, and advocacy options. After framing public health issues for affected individuals and the community, legal and policy approaches and related barriers are assessed. Major topics include deficits in housing availability, the role of state-based Medicaid programs, criminalization of homelessness, and the use of emergency declarations seeking to address particular issues related to homelessness in select states and localities.

The market can produce skewed information about investigational products awaiting FDA approval. But the FDA rarely steps in to correct such misleading information, despite statutory authority to do so. This article evaluates a recommendation by the FDA Transparency Working Group that FDA more clearly signal when and how it will correct misleading information about investigational products, and why such a recommendation is particularly important after the 21st Century Cures Act.